Phase 4 N=30 Randomized Treatment

A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction

Hyperlipidemia · Hypercholesterolemia

Bottom Line

View on ClinicalTrials.gov: NCT00203476 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: LDL Goal Attainment — 6; 6; 9 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Niacin (Drug); Colestipol (Drug); Ezetimibe (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Tuscaloosa Research & Education Advancement Corporation
Primary completion: Jan 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY LDL Goal Attainment	6; 6; 9	—
SECONDARY LFT Elevation	1; 1; 2	—
SECONDARY Incidents of Rhabdomyolysis	0; 0; 0	—
SECONDARY Change in HDL From Baseline to 12 Weeks.	42.33; 39.22; 32.90; 43.00; 37.56; 34.70	—

Summary

To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or niacin. The patient's cardiovascular risks are assessed to determine if National Cholesterol Education Program's Adult Treatment Panel III (NCEP ATP III) guidelines for low density lipoprotein (LDL) reduction were achieved between the three groups. Secondary measures examine the safety issues with liver function test (LFT) monitoring and rhabdomyolysis. High-density lipoproteins (HDL) elevations are monitored between the three groups to determine efficacy as a secondary outcome.

Eligibility Criteria

Inclusion Criteria

Veterans eligible for treatment at the Tuscaloosa VA Medical Center
50 years of age
Male or female
Any race or ethnic group
Signed informed consent
Hyperlipidemia despite current maximum tolerated dose of an HMG CoA Reductase inhibitor (statin) for > 6 weeks
Currently not meeting NCEP ATPIII treatment goals for LDL cholesterol

Exclusion Criteria

Known hypersensitivity or intolerance to ezetimibe, niacin, or colestipol
Previous failed adequate trial of adjunctive ezetimibe, niacin, or colestipol
Consumes more than 8oz. grapefruit juice daily
Significant medical condition that would impact safety evaluations (i.e. significantly elevated LFT, hepatitis, severe dermatitis, uncontrolled diabetes, severe GI disease, fibromyalgia, renal failure, recent CVA or MI, pancreatitis, etc.)
Receiving medications that would be contraindicated to use in combination with ezetimibe, niacin, or colestipol

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00203476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.